Plain English Summary
Background and study aims
Infectious diarrhoea is a major threat to human health and treatment with antibiotics has led to resistant bacteria. Prevention and management of dehydration is standard care but does not reduce the duration of diarrhoea. The aim in this study is to assess the usefulness of a plant extract (LiveXtract) in reducing the duration of diarrhoea in children and adults.
Who can participate?
Male patients, age 6 months old to 60 years old, presenting with acute diarrhoea
What does the study involve?
Patients will be randomly allocated to one of two groups: LiveXtract mixed with ORS or water mixed with ORS. They will be monitored for up to 4 days.
What are the possible benefits and risks of participating?
A benefit is the reduction in the duration of diarrhoea. A risk might be a reaction to the LiveXtract solution.
Where is the study run from?
Dhaka Hospital (Bangladesh)
When is the study starting and how long is it expected to run for?
From July 2011 to October 2017
Who is funding the study?
LiveLeaf Inc (USA)
Who is the main contact?
Dr Thomas Lawson
tlawson@liveleaf.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Thomas Lawson
ORCID ID
http://orcid.org/0000-0001-5182-4681
Contact details
1160 Industrial Road
Suite 11
San Carlos
94070
United States of America
+16505177288
tlawson@liveleaf.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PR-11036
Study information
Scientific title
Assessment of the therapeutic effect of LiveXtract, a novel plant extract, on the severity and duration of infectious diarrhoea in children and adults: a randomised double-blind placebo-controlled study
Acronym
Study hypothesis
Use of the LiveXtract mixed with oral rehydration solution (ORS) will reduce the duration of diarrhoea compared with ORS alone.
Ethics approval
ICDDR,B Ethical Review Committee, 29/12/2011, PR-11036
Study design
Interventional randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Diarrhoea
Intervention
1. LiveXtract solution mixed with ORS
2. Water mixed with ORS
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Reduction in the severity and duration of diarrhoea, measured as the time the stool is ranked as a 4 or less on the Bristol Stool Scale
Secondary outcome measures
1. Volume of ORS consumed from the time of randomisation to resolution of diarrhoea
2. Number of events and duration of emesis
These outcomes will be monitored every 6 hours for 4 days and ranked with a Visual Analogue Scale of 0 to 10.
Overall trial start date
04/07/2011
Overall trial end date
01/10/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 6 months old to 60 years old
2. Acute watery diarrhoea (for 48 hours or less)
Participant type
Patient
Age group
Mixed
Gender
Male
Target number of participants
The target total recruitment of participants is 736 patients.
Total final enrolment
85
Participant exclusion criteria
1. Fever
2. Bloody stool with or without abdominal pain
3. Clinical signs of coexisting severe acute systemic illness
4. Underlying severe chronic disease
5. Severe malnutrition
6. Signs of internal bleeding or black stools
7. Signs of drug abuse
8. Food allergy or other chronic gastrointestinal disease
9. Use of antibiotics or any anti-diarrhoeal medication during the previous 2 weeks
10. Any condition that the admitting physician believes will place the patient at risk if enrolled in the study
11. Participants whose stool cultures show Shigella spp
12. Unable or unwilling to provide informed consent
Recruitment start date
10/05/2012
Recruitment end date
01/10/2017
Locations
Countries of recruitment
Bangladesh
Trial participating centre
Dhaka Hospital
68 Shaheed Tajuddin Ahmed Sarani
Dahaka
1212
Bangladesh
Sponsor information
Organisation
LiveLeaf Inc
Sponsor details
1160 Industrial Road
Suite 11
San Carlos
94070
United States of America
+16505177288
tlawson@liveleaf.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Liveleaf Inc
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
This study is running in two phases: a pilot study for safety data, with submission of the results before April 2015; the second phase will begin in the summer of 2015 and is likely to last 18 months and these data will be submitted to a peer-reviewed journal before the end of 2016.
Intention to publish date
30/04/2015
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4576009/ (added 05/03/2019)